February 2024: Notable Drug Approvals

Drug

Pharmacologic Class

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Allergic Disorders
Xolair (omalizumab) Anti-immunoglobulin E (IgE) antibody For the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to 1 or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. Xolair Approved for Adults and Pediatric Patients With IgE-Mediated Food Allergy
Dermatological Disorders
Aurlumyn (iloprost) Prostacyclin mimetic Treatment of severe frostbite in adults to reduce the risk of finger or toe amputation. FDA Approves Aurlumyn for Treatment of Severe Frostbite
Gastrohepatic Disorders
Eohilia (budesonide oral suspension) Corticosteroid Treatment of adults and pediatric patients 11 years of age and older with eosinophilic esophagitis. Eohilia, an Oral Therapy for Eosinophilic Esophagitis, Gets FDA Approval
Infectious Diseases
Exblifep (cefepime/enmetazobactam) Cephalosporin antibacterial plus a beta-lactamase inhibitor Treatment of patients 18 years of age and older with complicated urinary tract infections, including pyelonephritis. Exblifep Approved for Complicated UTI, Including Pyelonephritis
Neurologic Disorders
Motpoly XR (lacosamide) Anticonvulsant Treatment of partial-onset seizures in adult and pediatric patients weighing at least 50kg. Motpoly XR, a Once-Daily Formulation of Lacosamide, Now Available
Oncology
Amtagvi (lifileucel)
Tumor-derived autologous T cell immunotherapy
Treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. One-Time Cell Therapy Amtagvi Gets Accelerated Approval for Advanced Melanoma
Onivyde (irinotecan liposome)
Topoisomerase inhibitor
In combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma. Onivyde Regimen Approved as First-Line Tx for Metastatic Pancreatic Adenocarcinoma
Tagrisso (osimertinib)
Kinase inhibitor
Treatment of adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer. Tagrisso Approved for First-Line Tx of EGFR Mutation Positive Advanced NSCLC
Tepmetko (tepotinib)
Kinase inhibitor
Treatment of adults with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 (MET ex14) skipping alterations. Tepmetko Gets Traditional Approval for MET Exon 14-Skipping NSCLC